It says multinational suppliers, not Chinese companies, will reap most of that bonanza.

In a news release promoting a new report about the Chinese market, InMedica says shipments of analog X-ray equipment to China will decline at a compound annual growth rate of 14.2 percent over the next five years while the overall Chinese X-ray market increases at a compound annual growth rate of 9.5 percent.

According to the release, the Chinese government, as part of a health-care reform announced in 2009, bought a lot of analog equipment for rural clinics. Many of those clinics are now trying to upgrade to digital.

China’s larger hospitals, in both rural and urban areas, are also going digital. The release says level 3 and large level 2 hospitals are looking to digital X-ray equipment to increase revenue. Once a hospital reaches its effective capacity of 100 daily patient scans per digital radiography (DR) system, it’s ready to buy an additional system.

The release quotes Owen Tang, a Shanghai-based analyst for InMedica, as saying that “almost all new systems purchased by these hospitals will be high-specification flat panel detector-based DR X-ray.” He added:

Unlike other kinds of X-ray equipment, such as mammography and fluoroscopy X-ray, DR equipment can help hospitals increase their revenue stream based on their more frequent use. In fact, return on investment is a critical factor for hospitals making a purchase decision, as current investment from the government is not enough.

Most of this new equipment will come from multinational companies, the release says: “Most level 3 hospitals and big level 2 hospitals [are] only willing to purchase the equipment from nondomestic suppliers.” Chinese manufacturers are concentrating their marketing on county-level hospitals.

No wonder GE Healthcare last year moved the global headquarters of its X-ray business to Beijing.

Related seminar: The Business of Radiology

In Keillor’s fictional Lake Wobegon, all the women are strong, all the men are good-looking, and all the children are above average. At the much less bucolic FDA, some scientists and doctors are fighting with administrators over approval of radiological devices, and the administrators are fighting back by monitoring the staffers’ personal e-mail.

Meanwhile, the FDA announced a tentative deal with medical device makers that would double its user fees in exchange for a faster and more transparent device-review process.

So, kind of a roller-coaster week.

Last week began with the news that six former and current FDA staffers, including two doctors and an MD/PhD, had filed a lawsuit alleging that the agency had spied on their nonwork e-mail, which the staffers had accessed through work computers. The suit also charges that the FDA fired or otherwise retaliated against them for leaking documents to Congress and the press.

Science magazine has a good summary of the situation, including a link to the lawsuit. What’s most significant for the medical community and the public is the viciousness of the infighting as FDA managers push for approval of radiological devices against the advice of their own medical and scientific experts.

The Washington Post points out:

Most of the devices the scientists and doctors questioned have received approvals only in the past two years, making it difficult to evaluate whether the fears that the FDA scientists and doctors expressed were valid.

Against that backdrop, the FDA announced on Wednesday the user-fee agreement, which is intended to speed up that very same approval process for medical devices. DOTmed News quoted Stephen Ubl, president of the Advanced Medical Technology Association trade group, as saying:

We believe this agreement is a potential game changer for the FDA, for industry, and, most importantly, for patients and the American economy.

The FDA said the agency would collect $595 million, plus adjustments for inflation, in user fees over five years, allowing it to hire more than 200 full-time-equivalent workers. “The FDA and the industry expect that the agreement in principle would result in a reduction in average total review times,” said the agency’s announcement.

Great. But the FDA has to do a better job in balancing the legitimate economic and political pressure to get useful devices approved with its duty to make sure that the devices are indeed useful as well as safe.

The Washington Post story quotes one of the lawsuit plaintiffs as saying a team of FDA experts three times recommended against approving a computer-aided imaging device for detecting breast cancer. Each time, the plaintiff said, middle managers agreed. Then, after the third rejection, a senior manager approved the device.

Something’s wrong, and adding more money and more staff won’t fix it.

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Meanwhile, the device industry still hates an upcoming excise tax; see our Facebook page.

Related seminar: Radiology Review Course

She had a doctor’s order. She had insurance coverage. She’d had a breast ultrasound. She had a family history of breast cancer and a personal history of breast lumps. She’d had a benign breast lump removed the previous year, after an ultrasound and a mammogram.

But she was 26. Both facilities, she said, told her she was too young for a mammogram.

Katie Schaber responded by e-mailing WKMG-TV Local 6 news in Orlando. The station contacted Libby’s Legacy Breast Cancer Foundation of Orlando, which in turn contacted the Women’s Center for Radiology in Orlando.

In January, Schaber got her 3-D mammogram, which did find an anomaly in her left breast. A follow-up MRI at the Women’s Center found no problem. The center advised Schaber to have another follow-up in six months and a mammogram every year.

Julie Miller, MD, a diagnostic radiologist at the Women’s Center, told Local 6 she has seen girls as young as 17 with breast cancer. Dr. Miller added:

If the patient is young, you would start with an ultrasound to minimize radiation. But you certainly wouldn’t stop at that point just because of her age.

Schaber had gone to Sand Lake Imaging of Orlando in December, armed with her doctor’s prescription for an ultrasound and a mammogram. The clinic did the ultrasound but then declined to do the mammogram.

On her blog, Schaber wrote, “A doctor reviewed my ultrasound and said that, since I was so young and since he didn’t think the scan showed anything too serious, he wouldn’t do a mammogram.”

Sand Lake Imaging said federal law prohibited it from discussing the case.

Next, Schaber tried Florida Hospital Celebration Health of Celebration. Again, she said, she was told the hospital would do an ultrasound but not a mammogram.

Jennifer Roberts, media relations manager for the hospital, told Local 6:

We must abide by our accredited appropriateness criteria approved by the American College of Radiology for diagnostic mammography and breast ultrasound. These criteria recommend that women 29 and under receive an ultrasound and/or provide adequate health history, including previous exams, prior to performing a diagnostic mammogram.

Schaber, a reference librarian at Full Sail University in Winter Park, Florida, has detailed the story on a deeply personal (and award-winning) blog called from IF to when. It focuses on her diagnosis of infertility and its effects on her and her husband’s lives.

Regarding the mammogram issue, she told Local 6, “It seems a little odd to me that I have to keep fighting for something that so many women find uncomfortable. But I think that it is important.”

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Bad news for those who hoped soy isoflavone supplements might protect against breast cancer. See our Facebook page for details.

Related seminar: Breast Imaging and Intervention: A Comprehensive Review (discount and free shipping)

Dense breast tissue may mask tumors on a mammogram and is a risk factor for breast cancer.

Senator Karen Mayne, D-West Valley City, is sponsoring the legislation. According to the Deseret News newspaper of Salt Lake City, she told the Utah Senate Health and Human Services Committee last week:

Today I bring you a bill of love. I don’t want my sisterhood to have any more tragedy, loss of life, loss of income.

The committee unanimously voted to send the legislation to the Senate floor, though one committee member said he had reservations. “I have a general concern in incorporating suggestions into our code,” said Senator Mark Madsen, R-Lehi. He said he also didn’t like legislating the practice of medicine, though he didn’t object to the notification recommendation itself.

The Utah Medical Association supported the amended legislation, said Michelle McOmber, executive vice president:

Part of the reason why we didn’t want a mandate was because health care changes so quickly. We feel good with the amendment.

Mayne said she would have preferred the original bill’s mandate. “We need something that has some teeth,” she said.

McOmber said women can already learn about their breast density from their primary-care physician, who receives a detailed mammogram report from the radiologist. But Senator Luz Robles, D-Salt Lake City, said that wasn’t enough. Women shouldn’t have to ask for that information, she said.

“It’s not because we don’t want to know,” she said. “You expect to get information that is relevant to your health.”

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Happy Monday. To make your Monday even happier, or at least a little more interesting, check out our Facebook page.

Related seminar: Breast & Women’s Imaging Seminar

Terahertz waves, also known by the much cooler-sounding name “T-rays,” are in the far-infrared part of the spectrum—some say between the microwave and infrared zones. Their wavelengths are hundreds of times longer than those of the rays in the visible light spectrum. Their most common use right now is in airport security scanners.

T-rays have great potential for medical imaging applications. They don’t penetrate deeply into the body. But each type of molecule has its own unique signature in the T-ray range. So T-rays can distinguish between, for example, normal cells and cancerous cells. They can also detect such phenomena as increased blood flow around tumors.

Researchers have just announced a breakthrough that focuses T-rays into a much stronger directional beam than had been possible, and at room temperature. For details, see a study published online this month in Nature Photonics. Previously, T-ray generators had to operate at very low temperatures, which is expensive.

Stefan Maier, PhD, a coauthor of the study, sees vast potential:

T-rays promise to revolutionize medical scanning to make it faster and more convenient, potentially relieving patients from the inconvenience of complicated diagnostic procedures and the stress of waiting for accurate results.

The idea is to use T-rays in a portable sensing, computing, and data communications device, like the tricorder of Star Trek fame. Dr. Maier was quoted in a news release from Imperial College London, where he is a physics professor.

T-rays’ possibilities intrigue others as well. Rensselaer Polytechnic Institute of Troy, New York, has created a Center for Terahertz Research that encompasses four separate laboratories. According to its Web site:

Perhaps the greatest potential for this research lies in biomedical imaging and genetic diagnostics. T-rays offer hope for improved detection of breast cancer through sharper imaging and molecular fingerprinting.

However, there may be a complication. T-rays are not ionizing, and they don’t break chemical bonds. But some studies have reported genetic damage, possibly through interference with DNA. Other studies have found no such effects.

We’ll definitely be hearing more about T-rays. Stay tuned.

Related seminar: Radiology Review

The wafers have to be exactly the right shape and size to bind to breast cancer cells and not other types of cells, and their surface chemistry has to be just right as well. The scientists also attach a type of organic compound called a polyamine to the wafers to improve the solubility and the attraction to cancer cell surfaces. And they stuff a hollow gold particle inside each wafer.

Injected into the body, these precisely engineered nanoparticles cling to breast cancer cells. When targeted by a near-infrared laser, the particles heat up by about 20 degrees centigrade in seven minutes, cooking the cancer cells.

For details, see the study, published this month in the new journal Advanced Healthcare Materials.

The scientists said they were looking forward to testing their lab results in human clinical trials. The Research Institute’s Haifa Shen, MD, PhD, lead author of the study, said:

We are planning preclinical studies to study the technology’s impact on whole tissues, breast cancer cells, and possibly pancreatic cancer cells. We would also like to see whether this approach makes chemotherapy more effective, meaning you could use less drugs to achieve the same degree of success in treating tumors.

Dr. Shen was quoted in an institute news release.

Previous attempts to use hollow gold nanoparticles heated by a laser to destroy targeted cells in the body have not worked especially well, he said. “Multiple investigators have tried to use gold nanoparticles for cancer treatment, but the efficiency has not been very good. They’d need a lot of gold nanoparticles to treat a tumor.”

Hence the idea to stick the gold inside the precisely shaped silicon wafers—so tiny that they’re a 10th the size of a breast cancer cell. It’s a tricky process in many ways.

“The hollow gold particles we load into the porous silicon must be the right size and have the correct-sized space inside them to interact with the infrared light we are using,” Dr. Shen said. “But the wavelength of infrared we use will have to change depending on where the tumor is. If it’s close to the skin, we can use shorter wavelengths. Deeper inside the body, we have to use longer wavelengths of infrared to penetrate the tissue. The hollow space of the gold particles must be modified in response to that.”

Amazing. And very cool.

Related seminar: Breast Imaging and Digital Mammography

The WBC, one of the four major bodies that sanctions championship fights in boxing’s various weight divisions, appears to be offering mammograms for all female boxers, regardless of whether they compete in WBC-sanctioned bouts. It’s hard to tell for sure; the WBC is based in Mexico, and the announcement on its Web site appears to have been translated inelegantly into English from some other language.

The announcement says the WBC was making the offer “so that breast cancer can be prevented in accordance with the periods of time advised by physicians.”

It’s also possible that the WBC made the offer in order to take some heat off its longtime president, José Sulaimán. Sulaimán said last week after boxer Floyd Mayweather Jr. was convicted on a domestic-violence charge: “Beating a lady is highly critical, [but] it is not a major sin or crime.”

Sulaimán later apologized and blamed an imperfect command of English (his native language is Spanish).

In other breast cancer-related news, University of Missouri researchers found that mindfulness-based stress reduction can help breast cancer survivors improve their emotional and physical well-being. A study in the December issue of the Western Journal of Nursing Research details the results.

Jane Armer, PhD, a professor of nursing, was one of the researchers. She explained:

Postdiagnosis, breast cancer patients often feel like they have no control over their lives. Knowing that they can control something—such as meditation—and that it will improve their health gives them hope that life will be normal again.

Dr. Armer was quoted in a University of Missouri news release.

Mindfulness-based stress reduction incorporates meditation, yoga, and physical awareness. The program consists of eight- to 10-week group sessions during which patients practice meditation, discuss how their bodies respond to stress, and learn coping techniques. The researchers found that those who tried the technique lowered their blood pressure, heart rate, and respiratory rate.

The news release says the participants’ mood also improved, “and their level of mindfulness increased.” According to the study, “Mindfulness is a specific way of paying attention to what is occurring in the present moment.”

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It’s Friday; time for our last Facebook post of the week. You can find it here—and check out our Twitter feed here.

Related seminar: Breast & Women’s Imaging Seminar

University of Pennsylvania engineers coated iron oxide nanoparticles with glycol chitosan, a sugar-based polymer that reacts to acids. The sugar keeps the particles from binding or being absorbed by the body, but this particular formulation allows them to become ionized in acidic environments and thus attracted to such areas.

Enter the Warburg effect: Most healthy cells are aerobic, getting energy primarily from oxygen, but cancer cells are anaerobic, getting energy from glucose and turning it into lactic acid. Cancer cells also disrupt the blood flow around them, making it harder for the body to clear away the acid.

So acid-attracted iron oxide nanoparticles will cluster around tumors and make them stand out on MRI images. Said Andrew Tsourkas, PhD, who did the research along with graduate student Samuel H. Crayton:

One of the reasons we like our approach is that it hits a lot of tumors; almost all tumors exhibit a change in the acidity of their microenvironment.

Dr. Tsourkas, an associate professor of bioengineering at Penn’s School of Engineering and Applied Science, was quoted in a Penn news release. The research was published in the December 27 issue of ACS Nano.

The new coating could work well for other uses too, Dr. Tsourkas said:

You can take any nanoparticle and put this coating on it, so it’s not limited to imaging by any means. You could also use it to deliver drugs to tumor sites.

It gets better: The more malignant a tumor, the more it disrupts blood vessels, and therefore the more aciditic its environment. So the new nanoparticles do a good job differentiating malignant from nonmalignant tumors.

That could particularly benefit patients getting an MRI scan as a secondary breast cancer screen. MRI’s high sensitivity but low specificity can work against it, as Dr. Tsourkas explained: “The screening detects a lot of tumors, but many of them are benign. Having a tool like ours would allow clinicians to better differentiate the benign and malignant tumors.”

That explains why the research was funded partly by the Department of Defense Breast Cancer Research Program (yes, such a thing exists).

Related seminar: CT/MRI of the Abdomen and Pelvis

More than $8 million in grants from the National Cancer Institute (part of the National Institutes of Health) are fueling the initiative. It builds on advanced imaging tools that the center has developed over the past decade.

Zaver Bhujwalla, PhD, director of the center and principal investigator for the initiative, explained in a Johns Hopkins news release the scope of the effort:

By harnessing the very latest technology in noninvasive imaging—using any single or combination imaging modality of MRI, CT, SPECT, PET, laser optics, or ultrasound—we expect to develop tests that detect cancer faster and earlier, distinguish spreading or metastatic tumors from dormant ones, and develop better and more tolerable chemotherapy drugs that only attack cancerous cells, leaving healthy cells alone.

Wow.

Here are some specific lines of investigation:

• Using MRI to find proteins or other small molecules that could represent the earliest metabolic and biological changes in the formation of breast cancer.
• Using laser imaging to analyze collagen fibers in breast cancer tumors, which form distinctive patterns in metastatic cancer.
• Using SPECT, MR scanning, and optical- or laser-guided imaging to identify cancerous prostate cells by detecting a protein found only on such cells’ outside layer.
• Using PET scans to guide a viral-activated drug, bortezomib, to kill Kaposi’s sarcoma cells.

Other research teams will explore the speed of skin cancer progression, the amount of tumor shrinkage during pancreatic cancer treatment, the process by which cancer spreads to the lungs, and treatments to prevent the spread of kidney cancer to the bones.

This could be very exciting stuff. We’ll check back to see how things progress.

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Thanks to all of you for reading us this year. We’ll keep trying to be useful, interesting, and, yes, even fun in 2012. Please continue to check us out here at Radiology Daily, on our Facebook page, and on our Twitter feed. Happy new year!

Related seminar: Abdominal & Pelvic Imaging: CT/MR/US

The plaintiff’s attorney, William E. Artz of Arlington, Virginia, said the verdict covered future medical expenses (which he estimated at $250,000 to $300,000) and the mental anguish caused by worries about a possibly reduced life expectancy.

Both the patient and her husband testified about her fears for the future, Artz said. He added:

From a jury’s perspective, I think the mental anguish component is a fairly obvious one, even without her testimony.

Apparently so; the jury (four women, three men) took only an hour and a half to reach its verdict.

The case, decided on November 11, has not received wide publicity, and in fact we haven’t yet been able to determine the name of the plaintiff or the radiologist. Our information comes primarily from an article on a law firm’s Web site, which, naturally, mentions only the names of the lawyers for each side.

According to Artz, the plaintiff received a screening mammogram on September 15, 2008. The radiologist failed to notice an abnormality in the left breast. The plaintiff returned for her annual screening mammography 13 months later. At that time, the radiologist did notice abnormalities in the left breast. A diagnostic mammogram and ultrasound showed two masses. A biopsy revealed Stage IIIA breast cancer.

During the 13 months, the tumor grew from 2.5 centimeters to 8 cm, Artz said.

According to Artz, the radiologist conceded that she was negligent in overlooking the cancer the first time but contended that the cancer was slow-growing with no evidence of metastasis by the time of the trial. Defense experts testified that the 13-month delay in diagnosis did not change the patient’s prognosis or expected lifespan.

Artz, on the other hand, argued that the delay allowed the cancer to progress from a “curable” Stage IIA or IIB to an “incurable” stage.

The patient underwent neoadjuvant chemotherapy, a left quadrantectomy with reconstruction, radiation, and hormone therapy. The treatment was the same as if she had been diagnosed at the first mammogram, so the plaintiff did not seek compensation for past medical bills.

The radiologist’s lawyers filed a post-trial motion contending that the verdict was excessive. We’ll try to keep track of this case and dig up some more details.

Related seminar: Breast Imaging and Digital Mammography